MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423060
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the 2nd of 2 reports.Subject device is not available.
Event or Problem Description
It was reported that during coil embolization of an aneurysm located on the acom (anterior communicating artery) with sub arachnoidid bleeding, when placing the 4th coil, the 4th coil came out of the microcatheter stiff and stretched.Attempt was made to place the 4th coil but it broke off when trying to remove again.Eventually, the 4th coil was retrieved with the microcatheter, removing at the same time the 3rd implanted coil (subject device) that was locked to the 4th coil.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The device was returned protruding from an sl-10 microcatheter with another target coil.Visual and microscopic examination of the returned device confirmed that the coil had been detached electrolytically.It was also noted that the main coil was kinked/bent.The main coil was determined to have been placed successfully without issue initially.Issues were then experienced during placement of a subsequent target coil which caused the coil to be dislodged and removed with the microcatheter and the subsequent target coil.An assignable cause of caused by other will be assigned to this investigation.
Event or Problem Description
It was reported that during coil embolization of an aneurysm located on the acom (anterior communicating artery) with sub arachnoidid bleeding, when placing the 4th coil, the 4th coil came out of the microcatheter stiff and stretched.Attempt was made to place the 4th coil but it broke off when trying to remove again.Eventually, the 4th coil was retrieved with the microcatheter, removing at the same time the 3rd implanted coil (subject device) that was locked to the 4th coil.There were no clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7792367
• Report Number: 3008881809-2018-00357
• Device Sequence Number: 1249308
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: 04546540675880
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: M0035423060
• Device Lot Number: 19949048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER( STRYKER); TARGET COIL (STRYKER); EXCELSIOR SL-10 MICROCATHETER( STRYKER); TARGET COIL (STRYKER)